TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013

K051888 · Scantibodies Laboratory, Inc. · CEW · Oct 18, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051888
• Device Name: TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013
• Applicant: Scantibodies Laboratory, Inc.
• Product Code: CEW · Clinical Chemistry
• Decision Date: Oct 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1545
• Device Class: Class 2

Intended Use

This kit has been designed for the quantitative determination of total immunoreactive intact PTH (Total Intact PTH) in blood samples. The Total Intact PTH level is the sum of PTH (1-84) and N-truncated PTH fragments.

Device Story

Total Intact PTH IRMA is an immunoradiometric assay for quantitative measurement of parathyroid hormone in serum or plasma samples. Device utilizes coated tube technology; specific antibodies bind to PTH in patient samples. Used in clinical laboratory settings by trained technicians. Results assist physicians in diagnosing calcium metabolism disorders, specifically hypercalcemia and hypocalcemia. Provides objective hormone concentration data to guide clinical management of parathyroid-related conditions.

Clinical Evidence

No clinical studies performed. Bench testing included precision (intra-assay and inter-assay), linearity (1-2300 pg/mL), recovery (90.5-109.7%), dilution accuracy (77.2-108.1%), high-dose hook effect (up to 20,000 pg/mL), analytical specificity (no cross-reactivity to specified PTH fragments), and interference testing. Method comparison with predicate device using 243 samples yielded y = 1.05x - 2.20, r = 1.00.

Technological Characteristics

Immunoradiometric assay (IRMA) using polyclonal goat anti-PTH antibodies. Solid phase: antibody-coated tubes. Tracer: 125I-labeled polyclonal goat anti-PTH. Manual assay; no automated instrumentation required. Calibrators/controls derived from human serum. Analytical sensitivity ~1.0 pg/mL.

Indications for Use

Indicated for measuring parathyroid hormone levels in serum and plasma to assist in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.

Regulatory Classification

Identification

A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Submission Summary (Full Text)

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "U.S. Department of Health & Human Services (USA)" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The background is white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Michael Nordstrom OA/RA Manager Scantibodies Laboratory, Inc. 9336 Abraham Way Santee, California 92071

OCT 1 8 2005

Re: k051888

Trade/Device Name: Total Intact PTH Immunoradiometric Assay (Coated Tube Version) Regulation Number: 21 CFR § 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: II Product Code: CEW Dated: September 22, 2005 Received: September 28, 2005

Dear Mr. Nordstrom:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{1}------------------------------------------------

Page 2 --

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benson

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

6051888

510(k) Number (if known):

Device Name: Total Intact PTH IRMA (Coated Tube Version Assay) _______________________________________________________________________________________________________________

Indications For Use:

The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OVID) | |
|-------------------------------------------------------------------|---------|
| Division Sign-Off | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| Page 1 of 1 | |
| 510(k) | K051888 |
| 4.1-1 | |